The purpose of this pivotal Phase III study is to support the registration of canakinumab for the indication of gout in China, a replicate of global studies CACZ885H2356 & CACZ885H2357 by demonstrating in patients with frequent flares of gout for whom NSAIDs and/or colchicine are contraindicated, not tolerated or ineffective, canakinumab 150 mg s.c. given upon acute gout flares relieves the signs and symptoms and prevents recurrence of gout flares compared to triamcinolone acetonide 40 mg i.m.

A Randomized, Double-blind, Double-dummy, Active Controlled Study of Canakinumab (ACZ885) on the Treatment and Prevention of Gout Flares in Patients With Frequent Flares for Whom NSAIDs and/ or Colchicine Are Contraindicated, Not Tolerated or Ineffective

The change in the gout pain intensity in the target joint following ACZ885 administration measured by Visual Analog Scale (VAS) The time to first new gout flare [ Time Frame: at 72 hours post-dose, 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluate the time to 50% reduction of baseline pain intensity (measured on a 0-100 mm Visual Analog Scale) in the most affected joint affected by gout flare [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Evaluate the percentage of patients with at least 1 new gout flare [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Evaluate the efficacy of canakinumab compared with respect to the treatment of signs and symptoms of each acute gout flare [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

To evaluate the rescue medication use [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

To evaluate the efficacy of canakinumab with regards to inflammatory markers (high sensitivity C-reactive protein [hsCRP]) measured in the serum [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01362608